BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2841937 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10628
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 25, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V020549, IMPLANTED: 2007-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3037, LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A LOSS OF THERAPEUTIC EFFECT. IT WAS REPORTED THIS HAD OCCURRED SINCE THE BATTERY WAS CHANGED IN (B)(6) 2012 AND THEY RECEIVED A NEW PROGRAMMER. WHEN THE STIMULATION WAS TURNED UP THE PATIENT COULD FEEL IT AND WHEN THE PROGRAMMER WAS TAKEN AWAY SHE COULD NO LONGER FEEL IT. PATIENT HAS TRIED ALL FOUR PROGRAMS AND INCREASED STIMULATION IN EACH. STIMULATION WAS NOT RELIEVING THE PATIENT'S SYMPTOMS. PREVIOUS DEVICE SETTINGS HAD BEEN USED ON CYCLING, BUT AT THE LAST PROGRAMMING THE DEVICE WAS ON STEADY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1